Service Record Reviewer
As the incumbent of this quality role within Philips, your challenge will be to support Business Groups, Markets and enabling functions to always do the right thing.
The primary purpose of this position is to function in the role of a Service Record Reviewer for the ECR businesses. Service event reviewers review information provided about the field performance of our medical devices, providing evaluation as to whether these service events constitute complaints and generating actionable quality data for product quality improvement, thereby assuring compliance to worldwide regulations relative to medical device quality. Service event reviewers work in a team-based professional environment where each reviewer is expected to make most review decisions independently and to manage any backlog.
You are responsible for
• Work to develop and improve the Service Order review process while maintaining compliance with all FDA regulations.
• Support internal and external audits.
• Team work is embraced and highly regarded. Enforce and comply with the Philips Quality processes.
• Evaluate Service Orders in a timely manner for the need to investigate.
• Identify product characteristics and/or failures that could lead to a death or serious injury
• Review and code service orders to provide trending information necessary for Product Quality Monitoring.
• Assist product investigators in determining and identify potential systemic product issues.
• Provide proper verbiage and trending information on each complaint to ensure FDA compliance.
• Develop and maintain support systems knowledge including SAP, Clarify, OneEMS and Trackwise.
• Utilize creative problem solving techniques.
• Consistently being available to support our team in meeting all business objectives.
To succeed in this role, you should have the following skills and experience
• BS in technical discipline or equivalent education, experience, training
• Quality and/or Regulatory experience in a medically regulated and technical environment
• Demonstrated strong organization skills
• Must be able to work under pressure to meet regulatory reporting time frames and company requirements.
• Strong sense of responsibility and self-motivation with demonstrated ability to function independently and in a group environment.
• Requires the proven ability to consistently meet and/or exceed goals.
• Must be capable of making commitments, setting priorities, and delivering results on time.
• Able to exercise sound judgment within Philips using standard operating procedures and policies to determine appropriate action to achieve objectives